What is a Qualified Person (QP) and why must they be UK-resident?

A QP is responsible for certifying that each batch meets GMP standards. From 1 January 2025, MHRA requires that the QP be resident in the UK and named on an MHRA Manufacturing & Import Authorisation (MIA) license.

Can I still use a CDMO based outside the UK for manufacturing and then release in the UK?

Yes—this is feasible if you arrange shipment to a UK-based MHRA-approved MIA-licensed facility (or QP service) for testing, certification, and release.

What labeling changes are required for UK release?

From 01 Jan 2025, medicines must have “UK Only” labels, and EU FMD compliance barcodes must be removed or covered.

Do IMPs (Investigational Medicinal Products) require UK QP certification?

Yes. IMP batches need certification by a UK QP. If testing is done abroad, the QP must assure GMP compliance for import and release.

Are there alternatives to working with a full-service UK CDMO?

Alternatives include appointing a UK Responsible Person for Import (RPi) for EU CDMOs or using multiple service providers for manufacturing, testing, and release—though this often complicates logistics and regulatory oversight.

The Role of QPPVs in 2026: Navigating New Oversight & Accountability Rules

Overview

Qualified Person for Pharmacovigilance (QPPV) remains one of the most critical roles in pharmacovigilance. As regulatory updates take effect in 2026, especially the EU’s Implementing Regulation (EU) 2025/1466 and evolving UK guidance, the demands on QPPVs are increasing. This makes it more important than ever for Marketing Authorisation Holders (MAHs) to ensure that their QPPVs have clear authority, adequate support, and robust oversight systems in place.

If you want expert support in meeting these growing responsibilities, Sciom provides specialised QPPV services and full pharmacovigilance services.

Key Changes in Oversight & Accountability for QPPVs from 2026

Below are some of the most important regulatory shifts in 2025/2026 that QPPVs must navigate carefully:

Regulation / Guidance	What is Changing	Implication for QPPVs
EU Regulation 2025/1466 (effective 12 February 2026)	Only significant deviations from pharmacovigilance procedures need to be documented in the PSMF; clearer rules around subcontracting & audits; expanded requirements for signal monitoring; and the integration of EudraVigilance data.	QPPVs must review, update and enforce delegation agreements, ensure subcontractors are auditable, ensure internal PV systems integrate EV data for signal detection, and adjust PSMF content accordingly.
EudraVigilance (EV) Signal Monitoring	The pilot phase of EV signal monitoring is ending; from August 2025, MAHs across the EEA are required to monitor EV data and use it for internal signal management.	QPPVs will need to ensure workflows, SOPs and staffing are in place to review the EV database periodically, trigger signal validation, and report as per updated Good Pharmacovigilance Practices (GVP).
UK Post-Brexit QPPV & PSMF Requirements	UK MAHs must continue to appoint a QPPV, ensure PSMF is accessible from the UK, and if the QPPV resides outside the UK, a National Contact Person (NCP) must be appointed.	The QPPV must ensure UK obligations are met, including placing the PSMF in a location accessible within the UK, maintaining NCP responsibilities, and staying current with MHRA guidelines

Responsibilities QPPVs Must Reinforce in 2026

Because of these regulatory updates, QPPVs will be expected to strengthen or ensure competence in these areas:

1. Subcontractor and Delegation Oversight
Every subcontractor or vendor carrying out part of the pharmacovigilance tasks must have clear, documented agreements defining responsibilities, audit rights, reporting lines, and compliance with GVP. This is now more tightly regulated.

2. Signal Detection & Monitoring
QPPVs must oversee internal signal detection workflows that incorporate external sources (such as EudraVigilance), literature, and post-marketing data. Validated signals must be managed and escalated appropriately.

3. Plausible PSMF Content Updates
With Regulation 2025/1466, the Pharmacovigilance System Master File (PSMF) will need to include only significant deviations of PV procedures. QPPVs must review the PSMF regularly to ensure compliance and accessibility.

4. Regulatory Communication & Inspection Readiness
QPPVs must be fully prepared to respond to inspections or audits, both of their own company and of subcontractors. All oversight, deviations, and risk-management items should be traceable.

5. Benefit-Risk Management & Risk Minimisation
As regulatory expectations sharpen around risk-minimisation measures, QPPVs need to ensure risk management plans are up to date and properly implemented. Any updates required by periodic safety update reports (PSURs/PBRERs) or GVP modules must be actioned.

How Sciom Can Support QPPVs in 2026

As demands increase, partnering with a seasoned pharmacovigilance provider can ease the burden. Here's how Sciom helps:

QPPV Services: Sciom offers highly qualified, experienced QPPVs who understand EU and UK regulatory landscapes and help MAHs meet oversight, delegation, and reporting requirements.
Complete PV System Support: For robust oversight, Sciom provides full setup, maintenance, and improvement of pharmacovigilance systems SOPs, subcontractor management, PSMF creation and updates, signal detection, case processing, literature monitoring, etc.
Audit Preparation & Compliance AssuranceSciom helps ensure that all documentation, delegation agreements, PSMFs, and oversight mechanisms are inspection-ready.
Regulatory Writing & Reporting:Sciom can assist in preparing PSURs, risk management plans, and any regulatory or authority communication, ensuring accuracy and compliance with new requirements.

Best Practices for QPPVs to Follow Now

To ensure compliance and stay ahead in 2026, QPPVs can adopt the following best practices

Periodically review subcontractor contracts to ensure responsibility, audit and inspection obligations are clearly defined.
Maintain training programs so that all PV staff (internal and external) understand the updated duties and regulatory changes.
Establish or strengthen a signal detection unit or function inside the PV system that integrates internal and external sources, including EudraVigilance
Keep PSMF content lean but sufficient; make sure the document reflects only major deviations, their impact, and resolution.
Stay informed of updates to GVP guidelines, MHRA notifications, and any European Commission implementing regulations

FAQs

Regulation 2025/1466 requires that only significant deviations of PV procedures be included in the PSMF, that subcontractors are auditable and their roles documented, that marketing authorisation holders monitor EudraVigilance data consistently for signals, and update risk-minimisation efforts.

Yes, but with caveats. For UK authorised products, a QPPV may operate from the EU/EEA, but a National Contact Person (NCP) within the UK is required. The PSMF must be electronically accessible from a UK location.

All MAHs with products authorised in the EEA will be required to use EudraVigilance data as part of their internal signal detection processes. The pilot phase has ended. Validated safety signals will be managed internally according to updated workflows rather than through a separate notification format.

Under the new rules, the PSMF should include only significant deviations in PV procedures, their impact, and how they are managed. Minor or administrative deviations that don’t materially affect safety may no longer need to be included. However, all relevant safety information, risk minimisation measures, and oversight responsibilities must remain.

Sciom offers experienced QPPV services to ensure qualified oversight (see: Sciom QPPV service), full pharmacovigilance service (see: Sciom PV services), audit-ready documentation, subcontractor oversight, updated PSMF content, and regulatory writing. This helps MAHs meet the new oversight and accountability demands efficiently.

Conclusion

2026 brings new oversight and accountability expectations for QPPVs. From the EU’s Regulation 2025/1466 to refined UK requirements, QPPVs must reinforce their authority, ensure robust subcontractor oversight, integrate signal detection, and keep their PSMFs compliant and lean.

If you’re looking to ensure your pharmacovigilance system is fit for these changes, working with a trusted partner is essential. Sciom offers comprehensive QPPV services and pharmacovigilance Services. This ensures not only compliance but also patient safety and regulatory confidence.